Remote traction and guidance system for mini-invasive surgery

ABSTRACT

A guide and remote traction system for mini-invasive surgery in a body cavity that is easily positioned and hooked and causes lower injury, comprising:
         at least one detachable surgical endoclamp ( 10 ) with hooking means ( 11, 12 ), assembled with an introduction guide ( 20 ) and at an initially open position; and at a naturally closed position when detached from said introduction guide ( 20 ) by a detachment mechanism; said endoclamp ( 10 ) comprising a portion of ferromagnetic material at the end opposed to said hooking means ( 11, 12 );   a cylindrically-shaped introduction guide ( 20 ) assembled with said detachable surgical endoclamp ( 10 ), said introduction guide ( 20 ) comprising a mechanism to detach said endoclamp ( 10 ); and   at least one remote traction means ( 30 ) for said endoclamp ( 10 ), acting through the application of an electromagnetic field over the ferromagnetic portion of said endoclamp ( 10 ).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/337,082, filed Jul. 21, 2014, now issued as U.S. Pat. No. 9,844,391,which is a continuation of U.S. patent application Ser. No. 13/132,185,having a 371(c) date of Aug. 17, 2011, now U.S. Pat. No. 8,790,245,which is a National Stage Application of PCT/IB2009/054307, filed onOct. 1, 2009, which claims the benefit of Patent Application Serial No.279-2009, filed Feb. 6, 2009, in Chile, all of which are herebyincorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention is directed to a guide and remote traction systemfor mini-invasive surgery or endocavitary surgery, said system beingeasily maneuvered, positioned, hooked and used, which diminishes thenumber of required incisions to perform surgical procedures. Inparticular, the present invention consists in a guide and remotetraction system for mini-invasive surgery or endocavitary surgery thatis easily positioned and hooked, comprising: a detachable surgicalendoclamp; a detachable and self-closing introduction guide assembledtogether with said surgical endoclamp; and remote magnetic tractionmeans for said endoclamp.

BACKGROUND OF THE INVENTION

Surgery is under constant change and development. Currently, surgicalprocedures and technologies are oriented to carry out surgeries thatcause the lowest possible injury to the patient. The applied concept isto achieve advantages for the individual, such as lower pain, lowerpost-surgery recovery periods, shortened hospitalization, lowercomplications associated to the procedure and better cosmetic results,which results in a better life quality for the patient and savings forhealth insurance systems. With this inspiration, endoscopic or minimallyinvasive surgery has been developed, which allows carrying out surgicalinterventions through small incisions in the patient, hence avoidinglarger incisions and the higher metabolic costs of open surgery.

A solution to this need is disclosed in U.S. Pat. No. 7,169,104,published on Mar. 18, 2004, which discloses a remote guide anchoringsystem including an hooking device that is hooked to a body part in apatient's body; a magnetic clamp made of a magnetic material that isconnected to the hooking device; and a magnetic device located outsideof the patient's body to guide the clamp, which produces a magneticfield to move said magnetic clamp. As can be seen in this document andits figures, the invention in this document requires a second clamp toclose the magnetic clamp or to hook the clamp to the anchoring system.The former solution refers to a solution for digestive endoscopy that isvery difficult to apply in laparoscopic surgery since the assemblysolution for the clamp and its traction system is very difficult tocarry out inside cavities.

Technical Problem

These surgery techniques need entrance points into the individual, whichrequires performing a total wall incision and generally inserting aworking trocar (or port). Through these entrances, necessary elementsare introduced, both optical (cameras for internal visualization) andsurgical tools, e.g. clamps, electroscalpel, scissors, etc. In this typeof surgery, it is necessary to detach and raise adjacent organs ortissues for a cleaner and more effective surgery result. Usually, thisdetachment and rising is performed by using clamps or hooking means,which are directly manipulated from the outside through a working port.

These working ports are the incision points that must be performed inthe body wall of the individual, with the risks and complicationsassociated to a total thickness body wall incision, mainly: importantpost-surgery pain, intra- and post-surgery bleeding risk, infection riskand risk of developing subsequent hernias. All these complicationsdecrease the life quality of the patient and increase health insurancecosts. Additionally, there is also an important aesthetical issue, sincethese incisions necessarily leave a subsequent scar as a sequel. Due tothis, it is necessary to use the minimal possible number of incisions toperform the desired surgical procedure, therefore decreasing intra- andpost-surgery complications and hence getting the best post-surgeryresults.

Solution to Problem

The present invention solves the problem of positioning and effectivelyhooking an endoclamp to an organ or tissue to be pulled, making theassembly easy to use, since it comprises a self-closing endoclampactuated from the introduction guide. Subsequently, this endoclamp ismoved by applying a magnetic force through the body wall using theremote traction means.

Advantageous Effects of Invention

The present invention has been realized, consisting in a guide andremote traction system for mini-invasive surgery with easy positioningand hooking and lower injury since it makes possible to eliminate one orseveral incisions performed with the previous art techniques, whichbrings about a benefit for patients. This allows a significant reductionon the recovery time of patients, removing potential risks associated toincisions and avoiding undesirable scars. Furthermore, the presentinvention proposes a guide and remote traction system comprising ahooking mechanism to the organ or tissue to be treated that is easilyand safely operated, which facilitates its use by physicians. Therefore,the present invention is beneficial, since it decreases the number ofincisions to perform the surgery and is easily used. The presentinvention solves a problem of positioning and effective hooking to theorgan to be pulled, allowing an easy use and performing surgery withlower injury to the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a mini-invasive surgery, particularly alaparoscopic cholecystectomy, according to the previous art.

FIG. 2 is a schematic view of a mini-invasive surgery with the guidesystem with remote traction according to the present invention. Adecrease in the number of access points can be observed.

FIG. 3 is a schematic view of the guide system and remote tractionaccording to the present invention in an initial configurationcomprising an introduction guide and an assembled open clamp.

FIG. 4 is another schematic view of the guide system and remote tractionaccording to the present invention in a detachment position with aclosed clamp.

FIG. 5 is a schematic view of the endoclamp detached from theintroduction guide in traction operative position.

FIG. 6 shows a plot of magnetic field density as a function of distancegenerated by a remote traction means according to the present invention.

FIG. 7 shows a plot of magnetic field force as a function of distancegenerated by said remote traction means over an endoclamp according tothe present invention.

FIG. 8 shows a plot relating the magnetic induction of a traction meanswith a rare earth magnet with the force generated over an endoclamp bysaid magnetic induction, said traction means and said endoclampaccording to the present invention.

FIG. 9 shows a plot of magnetic induction as a function of voltage overan electromagnet of a traction means according to the present invention.

PREFERRED EMBODIMENT OF THE INVENTION

The present invention consists in a guide and remote traction system formini-invasive surgery in a body cavity that is easily positioned andhooked and causes lower injury, comprising:

-   -   at least one endoclamp with surgical hooking means, assembled        with a guide and at an initially open position; and at a        naturally closed position when detached from said guide by the        detachment mechanism; said endoclamp comprising a portion of        ferromagnetic material at the end opposed to said hooking means;    -   a cylindrically-shaped introduction guide assembled with said        detachable surgical endoclamp, said guide comprising a mechanism        to detach said endoclamp;    -   at least one remote traction means for said at least one        endoclamp, acting through the application of an electromagnetic        field over the ferromagnetic portion of said endoclamp from        outside of said body cavity.

As observed in FIG. 1, a mini-invasive laparoscopic-like surgery isperformed by techniques of the prior art in which, in this case, 4incisions are practiced in the abdominal wall to place the trocars,wherein 1 trocar (a) is used for insertion of an endoscopic camera, and3 trocars (b, c and d) are used to rise, manipulate and section theorgan to be treated, e.g. the gall bladder (v), with hooking means suchas conventional laparoscopic clamps.

Instead, FIG. 2 shows a mini-invasive surgery using the guide system andremote traction according to the present invention; wherein it can beappreciated that only one incision is carried out in the abdominal wallfor only one trocar (a), through which one or more clamps (p) areintroduced, which are driven by one or more magnets or electromagnets(e) to manipulate the organ (v); the endoscopic camera to visualize themini-invasive surgery is introduced through this same trocar, as well asan element to dissect and subsequently extract the tissue or organ.

As illustrated in FIG. 3, the guide and remote traction system formini-invasive surgery in a body cavity that is easily positioned andhooked and causes lower injury, comprises: an introduction guide (20)assembled with a detachable surgical endoclamp (10) and a remotetraction means (30) of said endoclamp (10) to move said endoclamp byapplying a magnetic field over an end of said clamp from the outside ofsaid body cavity, e.g. an electromagnet.

Said endoclamp (10) comprises two separate pieces substantially at itscenter and rotatable about an axis (11), each of said separate piecesdefining a hooking end (12) and a handling end (13) with a radial spring(not shown in the Figures) that holds the endoclamp (10) in itsnaturally closed position. A first handling end (13) is joined to aprojection (14) coupled to a cylindrical butt means (15) with a diameterwider than projection (14), and said butt means (15) extends to ananchoring means (16) introduced inside the guide (20); wherein the buttmeans (15) and anchoring means (16) comprise a portion made of aferromagnetic material, e.g. iron, nickel, cobalt, iron oxides, etc.

Said detachment mechanism of said introduction guide (20) comprises asecuring ring (21) joined to a first end of a substantially rod-likeconnecting piece (22), said connecting piece (22) passing through theinside of a guide tube (23), said guide tube (23) connecting at one endto the anchoring means (16) of the endoclamp (10) and at the other endto a detaching set (24) to detach said endoclamp (10); said connectionpiece (22) is joined at its second end to an unlocking piece (28)connected to a tensioned spring (26) fixed to the rear wall (25) of thedetaching set (24); said unlocking piece (28) having a perforation witha pin (29) passing therethrough. Said pin (29) is fixed at its end to anactuator (27) that is rotatable around a central axis (27 a) thatdefines an operative end (27 b) and an actuator end (27 c).

In an initial position, said rotatable actuator (27) is in a firstposition with the operative end (27 b) closer to the unlocking set (24)than the actuator end (27 c), which is far away from the unlocking set(24); the pin (29) passes through the perforation of the unlocking piece(28) and the unlocking piece is located at a distance from the rear wall(25) longer than the natural spring length (26) in such a way as to holdthe spring in tension in its first position. In this initial position,the connecting piece (22) holds the securing ring (21) around andjoining the handling ends (13) in such a way as to hold the endoclamp(10) open, i.e. with separated hooking ends (12).

When introducing the introduction guide (20) assembled with theendoclamp (10) through a trocar installed in a body cavity subjected tomini-invasive surgery, the introduction guide (20) and the endoclamp(10) can be guided, introduced and alignedly actuated through saidtrocar. When the endoclamp (10) is in its initial position, theendoclamp is open and is directed toward the organ or tissue (v) to betreated. When the endoclamp (10) is correctly placed at the organ ortissue (v), the endoclamp is put into a, unlock position, shown in FIG.4, which is achieved by pressing the actuator end (27 c) as to removethe pin (29) from the perforation of the unlocking piece (28); in thisway, the restriction imposed on the spring (26) is released and thespring returns to its natural position, bringing together the unlockingpiece (28) and the rear wall (25), and removing the securing ring (21)from the endoclamp (10) by means of the connection piece (22). In turn,the endoclamp (10) is released into its natural position, and thehooking ends (12) are closed, thus trapping the organ or tissue (v).

As shown in FIG. 5, when the endoclamp (10) is fixed to the organ ortissue (v), the introduction guide (20) is removed from the trocar andit can be used to introduce another element into the body cavity;furthermore, the endoclamp (10) is brought close to the body cavity wall(50) near the remote traction means (30) and the magnetic field isactivated in such a way as to make said endoclamp (10) to be attractedby said remote traction means (30) and orienting its butt means (15) andthe hooking means (16) toward the inner side of the body cavity wall(50). In this way, the remote traction means (30) can guide and positionthe endoclamp (10) remotely from the outside of the body cavity.

Then, in the aforementioned way, an organ or tissue in a body cavity canbe manipulated with one or more endoclamps by repeating the describedprocedure. The organ remains located in an optimal position to carry outthe corresponding surgical intervention with only one incision toinstall a single trocar.

Said one or more endoclamps remain fixed at their position or can bemoved along the body cavity, thanks to one or several remote tractionmeans of said endoclamp by applying an electromagnetic field over theferromagnetic portion of said endoclamp from the outside of said bodycavity.

Preferably, said remote traction means generates an electromagneticfield with a magnetic induction ranging from 0.1 to 1 Tesla (1,000 to10,000 Gauss) in the surroundings of said traction means, to generate aforce ranging from 2.94 to 4.9 N (300 and 500 grams) over the endoclampaccording to the present invention at a distance ranging from 10 to 30mm of the abdominal wall; reaching a body wall width of up to 80 mm incase of obesity. For this end, said remote traction means comprises apermanent magnet such as, e.g. a magnetized steel or Alnico (alloycomprising 24% by weight of cobalt, 8% by weight of aluminum, 14% byweight of nickel, 51% by weight of iron and 3% by weight of copper) orferrite (80% by weight of iron oxide and 20% by weight of strontiumoxide) magnet.

More preferably, said traction means comprises a rare earth mineralmagnet, e.g.: RE-M₅- and RE₂M₁₇-type, wherein “RE” is samarium (Sm),promethium (Pr) and neodymium (Nd) and “M” is a mixture of cobalt (Co)with metals such as iron (Fe), copper (Cu), zirconium (Zr), titanium(Ti), hafnium (Hf) and manganese (Mn); e.g. SmCo₅ made by GE ResearchLab in Schenectady, Nueva York (EEUU), or “neodymium-iron-boron”,Nd₂Fe₁₄B, developed in 1983 by Sumitomo (Japan) and General Motors(EEUU).

EMBODIMENT OF THE INVENTION

According to another preferred embodiment of the invention, said remotetraction means can comprise an electromagnet and a voltage regulator tovary the magnetic induction generated by varying the voltage on theelectromagnet. Preferably, said electromagnet generates anelectromagnetic field with a magnetic induction ranging from 0.1 to 1Tesla (1,000 to 10,000 Gauss) in the surroundings of said tractionmeans, to generate the required force over the endoclamp according tothe present invention at a distance ranging from 10 to 30 mm.

According to another preferred embodiment of the invention, said remotetraction means can comprise an electromagnet and an electric currentregulator to vary the generated magnetic induction by varying theelectric current intensity over the electromagnet, said magneticinduction ranging from 0.1 to 1 Tesla (1,000 to 10,000 Gauss) accordingto the present invention.

According to an embodiment of the present invention, said electromagnetcan comprise a paramagnetic material core that comprises one or severalof the following materials: air, aluminum, magnesium, titanium, ferricchloride and tungsten.

According to another embodiment of the present invention, saidelectromagnet can comprise a ferromagnetic material core that comprisesone or several of the following materials: iron, nickel, cobalt,aluminum, iron-silicon or alnico and permalloy alloys, this lattercomprising 20% by weight of steel and 80% by weight of nickel.

In a first example of the present invention, FIG. 6 shows a plot ofmagnetic field density as a function of distance generated by a remotetraction means according to the present invention which comprises a rareearth magnet. FIG. 7 shows a plot of magnetic field force as a functionof distance generated by said remote traction means over an endoclampaccording to the present invention. From FIG. 7, a characteristic magnetcurve can be interpolated using equation: (a) F=5.3757e^(−0.0967); witha quadratic fit with R²=0.9897, being F the force (in N) generated overthe endoclamp and d the distance (in mm) between the remote tractionmeans and the endoclamp; a magnet with these characteristics cangenerate 1.76 N (180 grams) at a distance of 11 mm according to thewidth requirements of the body cavity and the organ to be manipulatedwith the endoclamp of this first example.

According to the thickness of the patient's body cavity and the weightof the organ to be manipulated, in a second example a 2.94 N (300 grams)can be required to maintain and manipulate an organ through a bodycavity of 20 mm. Thanks to FIG. 7 and equation (a), a new characteristiccurve can be easily interpolated: 2.94=5.3757e^(−0.0967*20)+B; thereforeB=2.1628; and the resulting equation is: (b)F=5.3757e^(−0.0967*d)+2.1628; wherein for a 0 mm distance, said magnetmust generate a force of 7.5385 N (739 grams) over said endoclamp.

FIG. 8 shows a plot relating the magnetic induction of a rare earthmagnet with the force generated over the endoclamp according to thepresent invention, with the equation: (c) B=0.0917*F^(0.66); with aquadratic fit with R²=0.9915, wherein F is the force in Newtons and B isthe magnetic induction in Teslas; for this second example, the magnetrequired for the remote traction means according to the presentinvention should be dimensioned for a magnetic induction of 0.3478Teslas (3478 Gauss).

According to another preferred embodiment of the invention, said remotetraction means can comprise an electromagnet and a voltage regulator tovary the magnetic induction generated by varying the voltage on theelectromagnet. FIG. 9 shows a plot of magnetic induction as a functionof voltage over an electromagnet with a 2 A current I; a path length of8.3 cm; a spire number of 4.245; and a cold-laminated steel core with adiameter of 10 mm and permeability 1.99. Said plot of FIG. 9 allowsobtaining a characteristic electromagnet curve represented by equation:(d) B=0.1621*V^(0.5018); with a quadratic fit having R²=0.9956, whereinB is the magnetic induction in Teslas at a distance of 0 mm from theelectromagnet and V is the voltage in Volts applied over saidelectromagnet.

For the aforementioned example, where a 2.94 N (300 grams) force must begenerated over the endoclamp according to the present invention througha body wall of 20 mm, a magnetic induction of 0.3478 Teslas (3478 Gauss)should be produced at a distance of 0 mm; therefore, according to theplot in FIG. 9 and using equation (d), the required voltage isV=(0.3478/0.1621)^(1/0.5918)=4.58 Volts. Hence, the voltage regulator ofsaid traction means must be regulated to get the deduced 4.58 Voltsvoltage. In this way, the traction means that comprises an electromagnetwith a voltage regulator or a current regulator can be adjusted to applythe minimal necessary force over the endoclamp to hold it firmly at itsposition against the body cavity without applying an excessive forcethat could damage the tissues and other organs of the body cavity undersurgery.

INDUSTRIAL APPLICABILITY

The present invention has industrial applicability in the manufacturingindustry of mini-invasive surgery or endocavitary surgery tools. Thepresent invention is especially useful in videolaparoscopiccholecystectomy, but is not limited to this procedure.

The invention claimed is:
 1. A system for traction of tissue,comprising: a clamp comprising a first piece and a second piece, eachpiece defining an end for engaging tissue and a handling end; and anintroduction guide comprising an actuator and a detachment mechanismlongitudinally slidable within the introduction guide, wherein thehandling end of the first piece of the clamp is detachably attachable tothe introduction guide and comprises a portion made of ferromagneticmaterial, wherein the ferromagnetic material is configured to be atleast partially held within the introduction guide, wherein the actuatoris configured to retract the detachment mechanism away from the clamp toboth release the clamp from the introduction guide and fix the clamp totissue, and wherein the clamp is spring-biased toward a closed position.2. The system of claim 1, wherein the clamp is movable between an openposition and the closed position, and wherein the actuator is configuredto move the clamp between the open and closed positions.
 3. The systemof claim 2, wherein the first piece and second piece of the clamp arerotatable relative to an axis between the open and closed positions. 4.The system of claim 1, wherein the handling end of the second piece ofthe clamp is rotatable relative to an axis, and the detachment mechanismcomprises a rod held against the handling end of the second piece of theclamp when the introduction guide is assembled with the clamp.
 5. Thesystem of claim 1, wherein the actuator comprises an actuator end, theactuator end configured to move toward the clamp to retract thedetachment mechanism away from the clamp.
 6. The system of claim 1,wherein a predetermined amount of retraction of the detachment mechanismboth fixes and releases the clamp.
 7. A system for traction of tissue,comprising: an introduction guide comprising a detachment mechanismlongitudinally slidable within the introduction guide, wherein a distalend of the introduction guide comprises a tube; a clamp having open andclosed positions, wherein the clamp is detachably attachable to theintroduction guide; and a remote traction means to position the clampremotely from outside the body cavity, wherein the introduction guidecomprises an actuator configured to move the clamp between the open andclosed positions, wherein the actuator is further configured to retractthe detachment mechanism away from the clamp to both release the clampfrom the introduction guide and fix the clamp to tissue, and wherein theclamp is spring-biased toward the closed position.
 8. The system ofclaim 7, wherein the clamp comprises a ferromagnetic material, andwherein the remote traction means comprises a magnet.
 9. The system ofclaim 8, wherein a magnetic field generated by the remote traction meansis adjustable.
 10. The system of claim 7, wherein the clamp comprises afirst piece and a second piece, each piece defining an end for engagingtissue and a handling end, wherein the handling end of the first pieceof the clamp is detachably attachable to the introduction guide.
 11. Thesystem of claim 10, wherein the handling end of the first piece of theclamp comprises a portion made of ferromagnetic material.
 12. The systemof claim 10, wherein the first piece and second piece of the clamp arerotatable relative to an axis between the open and closed positions. 13.The system of claim 7, wherein a magnetic field generated by the remotetraction means is between 1,000 G to 10,000 G at about the remotetraction means.
 14. The system of claim 7, wherein the clamp comprises afirst end for engaging tissue, a second end opposite the first end, anda projection coupled therebetween, wherein the detachment mechanismcomprises a rod extending longitudinally out of the introduction guide,the rod held against the first end of the clamp when the introductionguide is assembled with the clamp.
 15. The system of claim 7, whereinthe actuator comprises an actuator end, the actuator end configured tomove toward the clamp to retract the detachment mechanism away from theclamp.
 16. The system of claim 7, wherein a predetermined amount ofretraction of the detachment mechanism both fixes and releases theclamp.